Ignite Creation Date:
2025-12-25 @ 3:45 AM
Ignite Modification Date:
2025-12-26 @ 2:32 AM
Study NCT ID:
NCT01040702
Status:
COMPLETED
Last Update Posted:
2009-12-30
First Post:
2009-12-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effect of Methylphenidate on Decision-making Ability of Attention Deficit Hyperactivity Disorder (ADHD) Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001289', 'term': 'Attention Deficit Disorder with Hyperactivity'}], 'ancestors': [{'id': 'D019958', 'term': 'Attention Deficit and Disruptive Behavior Disorders'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008774', 'term': 'Methylphenidate'}, {'id': 'D013549', 'term': 'Sweetening Agents'}], 'ancestors': [{'id': 'D010648', 'term': 'Phenylacetates'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D005421', 'term': 'Flavoring Agents'}, {'id': 'D005503', 'term': 'Food Additives'}, {'id': 'D000074385', 'term': 'Food Ingredients'}, {'id': 'D020313', 'term': 'Specialty Uses of Chemicals'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 58}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-12', 'completionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-12-29', 'studyFirstSubmitDate': '2009-12-29', 'studyFirstSubmitQcDate': '2009-12-29', 'lastUpdatePostDateStruct': {'date': '2009-12-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-12-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'score in decision-making task 1', 'timeFrame': 'by the end of the task'}], 'secondaryOutcomes': [{'measure': 'working memory task score', 'timeFrame': 'by the end of the task'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Attention Deficit Hyperactivity Disorder']}, 'descriptionModule': {'briefSummary': 'The aim of the study is to assess the effect of Methylphenidate on cognitive performance and decision-making ability of ADHD adults, and to compare this effect to the effect on healthy control adults.', 'detailedDescription': 'Two matched groups of adults - with and without ADHD diagnosis - will perform a battery of computerized tasks assessing sustained attention,working-memory,non-verbal IQ,and decision-making ability. In each group,half of the participants will perform the tasks after receiving a capsule containing methylphenidate (MPH), and the other half will perform the tasks after receiving placebo. Task performance measures will then be compared in order to assess the effect of MPH on these domains.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* adults in the age of 21-50\n\nExclusion Criteria:\n\n* pregnant or nursing women.\n* people who suffer from a psychiatric disorder other than ADHD which could account for their inattention symptoms better than ADHD.\n* people who lack judgment or are unable to communicate with the experimenters.\n* people who are incapable of performing the computerized tasks due to sensory or motor disabilities.'}, 'identificationModule': {'nctId': 'NCT01040702', 'briefTitle': 'The Effect of Methylphenidate on Decision-making Ability of Attention Deficit Hyperactivity Disorder (ADHD) Adults', 'organization': {'class': 'OTHER', 'fullName': 'Shalvata Mental Health Center'}, 'officialTitle': 'The Effect of Methylphenidate on Decision-making Ability of ADHD Adults', 'orgStudyIdInfo': {'id': 'SH-40107'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ADHD -MPH', 'description': 'adults with ADHD diagnosis who receive a single dose of Methylphenidate', 'interventionNames': ['Drug: methylphenidate']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'ADHD-placebo', 'description': 'adults with ADHD diagnosis who received placebo', 'interventionNames': ['Dietary Supplement: sweetener pill']}, {'type': 'EXPERIMENTAL', 'label': 'non-ADHD-MPH', 'description': 'healthy adults who received a single dose of Methylphenidate', 'interventionNames': ['Drug: methylphenidate']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'non-ADHD-placebo', 'description': 'healthy adults who received placebo', 'interventionNames': ['Dietary Supplement: sweetener pill']}], 'interventions': [{'name': 'methylphenidate', 'type': 'DRUG', 'otherNames': ['Ritalin'], 'description': 'a single doses of 10-20 mg in each one of two visits', 'armGroupLabels': ['ADHD -MPH', 'non-ADHD-MPH']}, {'name': 'sweetener pill', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['sukrazit'], 'description': 'a capsule containing a sweetener pill', 'armGroupLabels': ['ADHD-placebo', 'non-ADHD-placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hod HaSharon', 'country': 'Israel', 'facility': 'cognitive laboratory,Shalvata MHC', 'geoPoint': {'lat': 32.15934, 'lon': 34.8932}}], 'overallOfficials': [{'name': 'Ziv Carmel, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'MD'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shalvata Mental Health Center', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Ziv Carmel,MD', 'oldOrganization': 'Shalvata MHC'}}}}